Devices
FDA says it has notified 25 companies they should stop producing and issuing “FDA registration certificates” that deceptively indicate FDA approval, clearance, or authorization for medical devices. CDRH Office of Regulatory Programs director Sean Boyd says the agency has seen an increase in the number of companies selling medical devices
FDA Policy/General
As a follow-up to its 9/2019 Technology Modernization Action Plan, that laid out a foundation for modernizing the agency’s technical structure and signaled the development of its ongoing strategy concerning data management and data itself, the agency has now released a Data Modernization Action Plan. An online
Biologics
Shanghai Junshi Biosciences and Coherus Biosciences have begun a rolling BLA submission for toripalimab for treating recurrent or metastatic nasopharyngeal carcinoma (NPC). Toripalimab is the first anti-PD-1 monoclonal antibody developed and approved in China that has made it to a BLA submission in the U.S., the companies
Biologics
The National Institutes of Health (NIH) has stopped a clinical trial evaluating Covid-19 convalescent plasma in treating emergency department patients who developed mild to moderate Covid-19 symptoms. The NIH decision was recommended by the trial’s independent data and safety monitoring board, which recently examined the second planned
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Current Good Manufacturing Practice for Finished Pharmaceuticals, Including Medical Gases, and Active Pharmaceutical Ingredients (APIs) — 21 CFR Parts 210 and 211 and 21 U.S.C 351(a)(2)(B)” (OMB Control Number 0910-0139). The collection
Drugs
An 8/4-8/13/20 FDA bioresearch monitoring program inspection at KDunn and Associates, doing business as HealthQuilt, Houston, TX, found objectionable conditions in the company’s work as the sponsor of a clinical investigation into a Covid-19 investigational drug. A 2/16 Warning Letter says specific objectionable
Drugs
FibroGen and partner AstraZeneca say FDA is requiring its Cardiovascular and Renal Drugs Advisory Committee to review their NDA for roxadustat for treating anemia caused by chronic kidney disease (CKD). FDA accepted the NDA 2/2020 and gave it a review action target date of 12/2020, which was extended
Drugs
Drug companies are pressing FDA to find ways to resolve the inspection backlog that has occurred due to Covid 19. Politico reports in an online post that between 3/2020 and 9/2020 FDA inspected just three overseas plants (well below the 600-plus visited in each of the prior
Drugs
Merck has withdrawn a Keytruda (pembrolizumab) indication for treating patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. The withdrawal is part of an FDA effort to clean up products/indications on the
Drugs
FDA has approved revisions to the labeling for ViiV’s Triumeq (abacavir/dolutegravir/lamivudine) and Dovato (dolutegravir/lamivudine) to include dosing in patients with creatinine clearance between 30 and 49 mL per min. An agency notice says that drug interaction information for Triumeq and riociguat also was included in the
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a new information collection entitled “Generic Clearance for Data To Support Cross-Center Collaboration for Social Behavioral Sciences Associated with Disease Prevention, Treatment, and the Safety, Efficacy, and Usage of FDA Regulated Products.” Under the collection, FDA is seeking to conduct qualitative
Devices
The Department of Justice says global medical technology company Bioventus is paying over $3.6 million to resolve allegations that it violated the False Claims Act by submitting improperly completed certificates of medical necessity for medically unnecessary devices from 10/1/12 through 12/31/18. A department statement says
Devices
FDA has cleared Neurolief’s Relivion system, the first non-invasive, multi-channel brain neuromodulation system for at-home treatment of acute migraine. The company says that Relivion, worn as a headset, demonstrated statistically significant efficacy in providing complete freedom of migraine symptoms within two hours after treatment. The agency’
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: HealthQuilt, Houston, TX (2/16) FDA inspected the firm 8/4-8/13/2020 under its bioresearch monitoring program inspection and cited
Drugs
FDA has accepted an Oyster Point Pharma NDA for its OC-01 (varenicline) nasal spray to treat the signs and symptoms of dry eye disease. The agency assigned a PDUFA target action date of 10/17, the company says. It also says FDA currently does not plan to schedule an
Drugs
FDA has accepted for review an Eyenovia NDA for MydCombi (tropicamide 1% and phenylephrine 2.5%) ophthalmic solution, a fixed combination mydriatic (pupil dilation) agent for use in routine eye exams. “MydCombi was developed with the goal of providing a touchless fixed combination microdose formulation to improve the patient’s
Drugs
FDA 2/27 issued an emergency use authorization (EUA) to Janssen Biotech for its single intramuscular Covid-19 vaccine injection. The EUA follows an unanimous (22-0) advisory committee vote 2/26 (see earlier story). The company’s data “show that the vaccine’s known and potential benefits outweigh its
Devices
Medtronic is recalling (Class 1) its HeartWare Ventricular Assist Device (HVAD) Pump Implant Kit because the device may fail to initially start, restart, or have a delay in restarting after the pump was stopped. Such delays or failures to start or restart have occurred during pre-implant testing, during the
Drugs
In recognition of Rare Disease Day (2/28), FDA has announced new actions to advance development and approval of therapies to such diseases. For example, a new request for applications (RFA) has been posted within the agency’s Orphan Products Grants Program for “Efficient and Innovative Natural History Studies Addressing
Drugs
FDA has issued CorMedix a complete response letter on its NDA for DefenCath (taurolidine/heparin catheter lock solution) for use in kidney failure patients receiving chronic hemodialysis through a central venous catheter. The agency letter cited concerns at a third-party manufacturing facility after a review of records requested by
Drugs
FDA has accepted for review a Merck NDA for gefapixant, an investigational selective P2X3 receptor antagonist for treating refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults. An RCC is a cough that persists despite appropriate treatment of underlying conditions, and a UCC is a cough where the
Drugs
Bristol-Myers Squibb and three U.S.-based Sanofi subsidiaries have been ordered to pay $834 million to the state of Hawaii over marketing and promotion violations involving Plavix, a blood thinner used to reduce the risk of serious cardiovascular events such as heart attacks, strokes and blood clots. Hawaii